US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

PROPRANOLOL HCL Tablet

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014.

What was recalled

PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-530-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Propranolol recalls

See all
Class II · Moderate risk Terminated

Propranolol Hydrochloride Tablets

Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Cardinal Healthcare D-0194-2024
Class II · Moderate risk Terminated

Propranolol Hydrochloride Injection

Reason CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.

Fresenius Kabi USA, LLC NDC 63323-604-01 D-1545-2014
Class II · Moderate risk Terminated

Propranolol HCl

Reason cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Gyma Laboratories Of Amer,Inc D-0022-2015
Class II · Moderate risk Terminated

Propranolol Hydrochloride Tablets

Reason Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.

Teva Pharmaceuticals USA, Inc. NDC 50111-467-03 D-924-2013
Class II · Moderate risk Terminated

Propranolol HCL

Reason Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, Pedigree: AD60243_1, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003068, EXP: 6/12/2014.

Aidapak Services, LLC D-993-2014